Caucasian or Japanese subjects. Caucasian subjects are subjects of European descent; Japanese subjects must be first or second generation. Generations will be defined as follows:

First generation Japanese are subjects who may be living outside Japan but were born in Japan to parents of Japanese descent.

Second generation Japanese are subjects who were born outside of Japan to first generation Japanese parents.

Aged 18 to 65 years;

Body weight ≥50 kg;

Within BMI range 18.5 to 30 kg/m2, inclusive;

Healthy, as determined by the Investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead ECG. Creatinine and ALT levels must be strictly within the normal range for eligibility at Check-in;

Women of nonchildbearing potential must be surgically sterile (hysterectomy, oophorectomy, or tubal ligation) or postmenopausal for ≥1 year;

Women of childbearing potential must be using an effective nonhormonal method of contraception (intrauterine device or intrauterine system; condom or occlusive cap [diaphragm or cervical or vault caps] with spermicidal foam or gel or film or cream or suppository; true abstinence; or vasectomized male partner, provided that he is the sole partner of that subject) for a period of at least 1 month before and after dose administration. Women of childbearing potential must have a negative pregnancy test result within 48 hours before the start of the first investigational medicinal product (IMP) administration. Hormonal contraceptives will not be allowed because the effect of BIA 9 1067 on the metabolism of hormonal contraceptives and vice versa is not yet known;

Nonsmokers, defined as having smoked ≤10 cigarettes per week for the 3 months prior to dosing, abstained from smoking for 7 days prior to Check-in, and having a negative cotinine level ≤500 ng/mL at Check-in;

Have a high probability for compliance with and completion of the study, in the opinion of the Investigator;

Able to comprehend and willing to sign an ICF.

Exclusion Criteria:

Presence or history of any disorder that may prevent the successful completion of the study;

History of multiple and/or severe allergies to drugs or foods or a history of anaphylactic reactions;

Known or suspected allergy or other adverse drug reactions to the trial product or related products (eg, tolcapone or entacapone);

History of alcoholism or excessive daily alcohol consumption within the past year. Excessive alcohol consumption is regarded as an average weekly intake of more than 14 units for women and 21 units for men (1 unit of alcohol = 8 to 10 g and is approximately equivalent to 1 glass of wine or 250 mL of beer or a standard measure of spirits);

Involvement in other investigational studies of any type within 30 days of BIA 9-1067 administration;

Donation of blood within 90 days of Study Day 1;

Use of any prescription drug within 30 days of IMP administration unless deemed acceptable by the Principal Investigator (PI) and Medical Monitor;

Use of any over-the-counter drugs including herbal supplements (except for the occasional use of acetaminophen and vitamins ≤100% recommended daily allowance) within 14 days of Study Day 1 unless deemed acceptable by the PI and Medical Monitor.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01520987